MES Specialist *PC 1536

Your Role:

This position is in the Manufacturing Science and Technology team (MS&T) team. We are seeking a knowledgeable and proactive MES Specialist to support implementation and enhance our Manufacturing Execution System (MES) within a GMP-regulated manufacturing environment. This role requires sound technical skills in design/configuration/testing/validation of workflows / electronic batch records within our MES along with excellent problem-solving and communication abilities.

This role plays a key part in digitalizing GMP manufacturing processes and enhancing operational efficiency through well-structured and compliant MES workflows.

Additionally, this position will collaborate closely with internal and external stakeholders establishing partnerships to ensure compliance with cGMP and Quality Management systems to deliver our services to the clients effectively.

Essential Duties and Responsibilities:

• Support the lead engineer in the design, testing, validation, and implementation of MES workflows and master batch templates per GMP requirements.
• Support Integration of MES workflows with related systems such as ERP and manufacturing equipment into the MES workflows.
• Create and maintain technical documentation like manuals, operating procedures, validation test cases for MES workflow configurations and related systems.
• Own and manage timely completion of MES related Quality Events (QEs) such as deviations, investigations, CAPAs, and Change Controls in the quality system.
• Work in a cross-functional matrix environment, including Manufacturing, Quality Assurance (QA), Quality Control (QC), and Information Technology (IT) to understand requirements and implement MES solutions.
• Provide technical support for the MES platform by offering training and on call support to plant personnel.
• Maintain continuous coordination and communication with internal stakeholders and report regularly to the MES System Owner.
• Ensure MES designs adhere to GMP regulations and data integrity standards (21 CFR Part 11).

Requirements:

• A BS/MS degree in automation, industrial IT, engineering or a related field; At least 2 years of related experience in manufacturing execution systems and relevant software platforms: Or a combination of education and experience.
• Demonstrated experience in pharmaceutical or regulated manufacturing environments.
• Experience in implementing GMP manufacturing processes into MES workflows, with the ability to perform testing, documenting test conditions, and workflow validation related to MES system.
• Understanding of database systems and programming languages is advantageous.
• Technical support experience to diagnose and resolve MES software and integration issues.
• Experience in handling Quality Events (QEs) in the quality system.

Skills:

• Meticulous and logical in configuring, testing, documenting, and delivering MES solutions.
• Flexible in dynamic environments; effective in prioritizing tasks and managing projects.
• Excellent oral and written communication skills with technical writing ability
• Ability to work effectively with cross-functional teams and stakeholders.
• Project management skills including planning, execution, risk and change management
• Effective team player with analytical and problem-solving skills
• Good knowledge of Microsoft office
• Work with operations team to create a culture of accountability, ownership, and continuous improvement
• Job duties may include after hours on call support.
• Work across departments and/or sites.
• Work with process engineers and manager to align the priorities of the team with those of the department
• Able to work independently; shows initiative and able to work with all levels of staff.

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 50 pounds (dual lift). Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail. Must be able to travel routinely by car and plane.

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a sanitized laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment. The noise level in the work environment is usually moderate.

The hiring range for this position is expected to fall between $85,500- $93,050, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.

The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company's good faith and reasonable estimate of possible compensation at the time of posting.

In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions.

Miltenyi Biotec, Inc is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity

Miltenyi Biotec, Inc. participates in E-Verify.

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact - one breakthrough at a time. One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry - our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.